Lead Statistical Programmer

Senior Biostatistician SpecialistSummary of Job Responsibilities:This is a leadership role that oversees and executes all statistical programming activities for one or more therapeutic areas or compounds/indications within multiple studies/projects in various study activities. The goal is to ensure timely and high-quality programming deliverables in assigned projects and areas.The ideal candidate will be responsible for leading statistical programming activities, developing and maintaining programming documentations following programming standards and processes, creating CDISC standard SDTM mapping specifications and ADaM specifications, and developing and overseeing the development of SAS programs for the creation of SDTM and ADaM datasets following CDISC standards and reports.In addition, the candidate will contribute to the development of standard and utility macros, participate in establishing and maintaining statistical programming standards, participate in CRF annotation, review of SAP, TLFs specifications development and TLFs review, handle all P21 related items and eCRT package including aCRF, define.XML, cSDRG, ADRG and ARM for the regulatory submission to FDA/EMA/PMDA or other agencies, support global regulatory authority submissions following the guidelines (sdTCG, DSC, eCTD etc.) and working closely with partnering functions to address health authority requests.The candidate will also demonstrate company values by demonstrating excellence, competence, collaboration, innovation, respect, ownership, team work and accountability. They will understand the scope of work, plan and complete the deliveries and timelines with the study team, programming lead and management. Performing end-to-end programming activities, act as a team player and SME, focus on timelines and quality ensuring that programming deliverables meet regulatory submission requirements.Mentorship and coaching are also essential aspects of this role, requiring good collaborative skills and strong SAS programming skills in a clinical data environment with excellent analytical skills.Minimum Bachelor's degree in Statistics, Computer Science, Mathematics, Engineering, Life Science or related discipline with 7-8+ years of programming experience in processing clinical trial data in the biotechnology, pharmaceutical, CRO or health care related industry.Oncology Therapeutic area preferred.Strong SAS programming skills in a clinical data environment with excellent analytical skills. Working knowledge of other programming languages such as R, Python etc. is a plus.Great knowledge of pharmaceutical clinical development (i.e., understanding of statistical concepts, techniques, and clinical trial principles) and regulatory submissions (NDA, ANDA etc.).Extensive working knowledge of using and implementing CDISC standards, Regulatory guidance and TAUG. Prior PTL experience, attention to detail and able to adapt to a fast-paced environment.Ability to work independently and on global interdisciplinary teams. Good organizational, interpersonal, and communication skills. Positive attitude, team player and growth mindset.Problem solving and innovative skills that demonstrate initiative and motivation.Demonstrated and applied SAS programming skills. SAS certificates a plus.Opportunity to work on various projects across different therapeutic areas.Chance to develop and implement new processes and standards.Collaborative and dynamic work environment.Professional growth and development opportunities.This is an exciting opportunity for individuals who are passionate about biostatistics and want to make a meaningful contribution to the field. If you have a strong background in statistical programming and are looking for a challenging role, we encourage you to apply.